Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 23, 2017

Primary Completion Date

September 8, 2017

Study Completion Date

September 8, 2017

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

Belimumab

Belimumab will be provided as white uniform lyophilized cake in vials with unit dose strength of 400 mg/vial plus excipients (citric acid/sodium citrate/sucrose/polysorbate) for reconstitution in 4.8 milliliter sterile water for injection (SWFI). Belimumab will be administered as 10 mg/kg intravenous infusion for over 1 hour on Day 0.

Trial Locations (2)

215004

GSK Investigational Site, Suzhou

Unknown

GSK Investigational Site, Shanghai

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02880852 - Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus | Biotech Hunter | Biotech Hunter